Headband device for an oxygen mask, and method for the production thereof

ABSTRACT

The invention relates to a headband means ( 1 ) used for applying a breathing mask ( 2 ) in a user&#39;s facial area. Said headband means ( 1 ) comprises a flexible band body that is provided with upper and lower band portions ( 3, 4 ) and is used for transmitting the mask holding forces required for applying the breathing mask. At least some portions of the band body are made of a foamed plastic material. The invention further relates to an application device ( 102 ) for a breathing mask, comprising a headband means which extends around the back of a user&#39;s head. The headband means encompasses a supporting structure (S) made of a material that can at least once be temporarily brought into a state in which at least some portions of the headband means can be individually adjusted to the shape of the back of the user&#39;s head.

This application is a continuation of U.S. application Ser. No.10/578,864, filed Jun. 22, 2006, which is the U.S. national phase ofinternational application PCT/EP2004/012811 filed 11 Nov. 2004, whichdesignated the U.S. and claims priority to DE 103 52 608.0 filed 11 Nov.2003, and DE 103 52 607.2 filed 11 Nov. 2003, each of which isincorporated herein by reference in its entirety.

The present invention relates to a headband means for applying abreathing mask in a user's facial area. Furthermore, the presentinvention also relates to a method for producing a headband means ofthis kind. The present invention moreover relates to an applicationmeans for a breathing mask comprising a headband.

Breathing masks are used particularly in the medical and therapeuticalsectors for treating sleep-related respiratory disorders. Breathingmasks of this kind make it possible to supply a user with a breathablegas, in particular filtered ambient air, on a pressure level which liesabove the ambient pressure. This respiratory gas supply, which iscarried out at an increased pressure, makes it possible to achieve apneumatic splinting in the area of the upper respiratory passages inorder to thus prevent possible obstructions in the area of theserespiratory passages. The breathing masks which are used in such amanner for treating sleep-related respiratory disorders are worn by theuser during the entire rest and sleep periods. These breathing masks arenormally fixed to the head of the user by means of a headbandarrangement. These headband arrangements can comprise an upper headbandportion as well as a lower headband portion, wherein the upper headbandportion exerts corresponding holding forces on a forehead supportingmeans of the breathing mask. The breathing mask can be forced by thelower headband portion against the area surrounding the nose, the nosebridge area as well as the area of the upper lip.

It is the object of the present invention to provide a headband meanswhich can be produced advantageously in view of production engineeringand which stands out due to a high wearing and using comfort.

In accordance with a first attempt, this object is achieved with aheadband means for applying a breathing mask to a user and comprising aflexible band body having upper and lower band portions for transmittingthe mask holding forces required for applying the breathing mask,wherein at least portions of the band body are made of a foamed plasticmaterial.

It is thus advantageously possible to produce a headband means whichstands out due to its cushioning characteristics without considerablecutting losses as a mass-produced article.

In accordance with a particularly preferred embodiment of the presentinvention, the plastic material that is intended for forming the bandbody is molded to become the band body by injecting the plastic materialinto a corresponding mold space. The band body is advantageouslyconfigured such that it has a skin in the area of its outer surfaces.This skin effect can be achieved by providing the corresponding innerspace of the mold with a coating. The coating can be made, inparticular, in a powder coating process or by inserting films.

In accordance with a particularly preferred embodiment of the presentinvention, the band body is provided with a tensile stiff insert. Thistensile stiff insert is preferably made of a thermoplastic material, inparticular a nylon or polyamide material. At least portions of theinsert included in the band body can be configured such that in portionsit forms a dimensionally stable insert. The cushioning properties, inparticular the cushion thickness of the band body can vary such thatparticularly in band zones with increased contact pressure the cushionis thicker.

In accordance with a particularly preferred embodiment of the presentinvention, the band body comprises closure means for coupling a bandstrap or bracket portion or mask fixing elements in an adjustablemanner. It is thus possible to adjust the mask contact pressureprecisely by means of the headband means. The closure means preferablyhave a locking structure that is formed integrally with the headbandmeans. The locking structure can be configured such that a lockingeffect can be achieved on the basis of a force and/or a form-fitcoupling with a corresponding counter structure. It is possible toconfigure the locking structure such that it is formed in particularintegrally with the insert that receives tensile forces or is tensileproof. The tensile proof insert can be configured such that it exhibitsa specific bending behavior. This specific bending behavior can beachieved in particular by forming recesses in the tensile proof insertas well as by adjusting the thickness of the tensile proof insert.

In accordance with a particularly preferred embodiment of the presentinvention, the closure means comprise a slide means which can be lockedon the headband means in different closing positions. The slide meanscan comprise a locking mechanism for locking the slide means on thelocking structure.

In accordance with a further aspect of the present invention, theabove-mentioned object is also achieved by a process for producing aheadband means in which, within the scope of a first plastic injectionstep for forming a tensile stiff insert, a corresponding plasticmaterial is injected into a molding tool space configured so as to formthe insert, and within the scope of a subsequent plastic injection step,a pore-forming plastic material is injected in an enlarged mold space insuch a manner that the pore-forming material covers the tensile proofinsert at least partially so as to form a cushion portion.

The present invention moreover relates to an application device for abreathing mask, in particular for breathing masks for treatingsleep-related respiratory disorders.

In this regard, it is the object of the present invention to provide anapplication device for a breathing mask which allows a reliable fixingof a breathing mask and which stands out due to a high using comfort.

In accordance with the present invention, this object is achieved withan application device for a breathing mask comprising a headband meanswhich extends in the application position around the back of a user'shead, wherein the headband means comprises a supporting structure, andthis supporting structure is made of a material which can at least oncebe brought temporally in a state in which the headband arrangement is atleast in portions individually adaptable to the shape of the back of theuser's head.

It is thus advantageously possible to provide a headband arrangementwhich guarantees that the course of the headband portions which extendtowards the breathing mask is advantageously adapted to the individualshape of the mask user's head. Furthermore, it is also particularlyadvantageously possible to introduce the tensile forces applied via theheadband portions under a low surface pressure into the area of the backof the mask user's head.

The headband arrangement is preferably configured such that thesupporting structure rests on the back of the user's head at the heightof the ear or in the area of the end of the cervical vertebra.

In accordance with a particularly preferred embodiment of the presentinvention, the supporting structure is made of a material which isplastically deformable after having been heated to a temperature ofpreferably at least 30° C. The supporting structure can be heated, e.g.,in a water bath or by means of hot air.

The supporting structure is preferably made of a plastic material, inparticular a thermoplastic material. The supporting structure can beconfigured so as to form a stiffening layer which, in the not yetcompletely cured state, can, e.g., be adapted to the curvature of theback of the user's head. The supporting structure can comprise a cushionon the side which faces a user in the application position. This cushioncan be formed of a foamed and/or nonwoven material.

In particular in case the supporting structure is configured as a curvedplate element, the supporting structure has preferably openings. Thisincreases the supporting structure's permeability to vapor and avoids anexcess moistening of the headband means. It is possible to configure thesupporting structure such that it is releasably coupled with theheadband means. It is thus advantageously possible to separate theheadband means from the supporting structure and to clean the headbandmeans separately.

In accordance with a particularly preferred embodiment of the presentinvention, the supporting structure is configured so as to comprise armportions which extend from a main supporting surface portion along theheadband portions.

The supporting structure can be configured such that it comprises alower edge portion having two lower legs which extend in the applicationposition towards the cheekbone and/or in an area lying below thecorresponding earlobe in order to guide lower band portions of theheadband arrangement. It is thus advantageously possible to adjust thecourse of the lower headband portions across the cheek area of the useradvantageously to the individual head shape.

In accordance with a further aspect of the present invention, thesupporting structure is preferably configured such that it comprises anupper edge portion having two upper legs which extend from a startingzone in the neck area in a direction across the ear region.

Further details and features of the present invention can be taken fromthe following description in combination with the drawings in which

FIG. 1 a is a side view of a user with a breathing mask that is appliedby means of the headband means according to the present invention;

FIG. 1 b is a sketch for explaining a headband means according to thepresent invention;

FIG. 2 is a cross-sectional view of a band body without tensile stiffinsert;

FIG. 3 is a cross-sectional view of a band body for explaining a variantwith a tensile stiff insert;

FIG. 4 is a sketch for explaining a locking portion that is formed on aheadband according to the present invention;

FIG. 5 a is a side view for explaining the cross-sectional profile of aband body with a locking means formed integrally therewith;

FIG. 5 b is a slide means assigned to the structure according to FIG. 5a;

FIG. 6 a is a further cross-sectional variant of a band body with atensile stiff insert formed therein as well as locking means formedintegrally with the tensile proof insert;

FIG. 6 b is a sketch for explaining a slide means assigned to thelocking means according to FIG. 6 a;

FIG. 7 is a perspective sketch for explaining further details of aheadband for a breathing mask, wherein the headband is formed of afoamed material and comprises a tensile stiff insert and a locking meansformed integrally therewith;

FIG. 8 is a sketch for further describing the function of the headbandmeans according to FIG. 7;

FIG. 9 is a side view of a breathing mask user with a breathing maskthat is applied to the user by means of a headband arrangement;

FIG. 10 is a view of the area of the back of the mask user's head forexplaining a preferred shape of the headband arrangement in this area;

FIG. 11 is a sketch for explaining the configuration of an applicationdevice according to the present invention, which is separate from thebreathing mask arrangement;

FIG. 12 is a sketch for explaining a preferred cross-sectional shape ofthe application device in the area of the supporting structure.

The breathing mask user shown in FIG. 1 wears a breathing mask 2 that isapplied nasally by means of a headband means 1 according to the presentinvention. The breathing mask 2 is fixed by means of lower headbandportions 3 and upper headband portions 4. The headband means 1 is madeof a foamed plastic material by injecting the latter into acorresponding mold space portion within the scope of a plastic injectionstep.

The headband means 1 comprises locking means 5, 6 for attaching fixingmeans 7, 8 in an adjustable manner to the respective headband portion 3,4. The fixing means 7, 8 have respective bracket or strap portions 7 a,8 a, wherein further band portions 11, 12 extending towards thebreathing mask 2 are passed through these bracket or strap portions 7 a,8 a.

The headband means 1 is configured such that the lower headband portion3 extends from the neck area, below the ears across the cheek areatowards the breathing mask. The upper headband portion 4 extends fromthe area of the upper back of the head to the forehead area of the maskuser. The lower headband portion 3 and the upper headband portion 4provide the holding forces required for applying the breathing mask 2.

The lower headband portion 3 essentially determines the contact pressurebetween the breathing mask 2 and the area surrounding the nose of themask user. The tensile force prevailing in the upper headband portion 4essentially determines the contact pressure between a foreheadsupporting means 14 and the forehead of the mask user.

FIG. 1 b schematically shows a headband means 1 that is spread out in aplane. This headband means comprises the upper headband portions 4 aswell as the aforementioned lower headband portions 3. The headband means1 is made of a foamed material and comprises a tensile proof insert. Inthe area B that is marked by dot-dash lines, the tensile stiff ortensile proof insert is configured such that it has a particularly hightorsion stiffness around an axis extending essentially perpendicularlywith respect to the supporting area. It is thus possible to bend theband in the area of the lower headband portions 3 or to realize anoffset in this area so that the lower headband portions 3 can beadvantageously passed below the ear area of the user towards his/hercheek area. As indicated, the headband means 1 is provided with lockingstructures 5, 6 which are formed integrally therewith and will bediscussed below in more detail.

FIG. 2 shows an embodiment of the headband means according to thepresent invention which is entirely made of a pore-forming plasticmaterial.

FIG. 3 shows a cross-sectional sketch Q/Q for explaining a variant ofthe band body comprising a tensile stiff insert E. The tensile stiffinsert is made of a thermoplastic material, for example nylon orpolyamide. The tensile stiff insert E is embedded in a foam material M.The foam material M is injection molded to the tensile proof insert E.

FIG. 4 shows a sketch for explaining a locking structure 16 which isformed integrally with the tensile stiff or proof insert E in accordancewith a particularly preferred embodiment of the present invention. Thelocking structure 16 is realized as a transversely interlocked webportion and can have, in particular, the cross section shown in FIG. 5a. The web body of the locking structure 16 is configured so as to forma guide means for a slide element. The locking position of the slideelement on the web means is adjustable.

FIG. 5 b schematically shows a possible variant of the slide element tobe placed on the web means according to FIG. 5 a or according to FIG. 4.The slide element comprises a locking mechanism 17 (not shown in detail)which can be selectively engaged with the locking structure 16. Theslide element comprises a bracket or strap portion 18 for receiving aband portion 11, 12, as shown in FIG. 1 a.

FIG. 6 a shows a further cross-sectional variant of a headband meansaccording to the present invention in the area of the locking means.Here too, the head band body comprises a cushion layer M made of afoamed material as well as a tensile proof insert E embedded therein.Here too, the tensile proof insert E forms part of a locking means whichis received in the band body in an almost sunk-in manner, in contrast tothe variant according to FIG. 5 a. A slide element can be inserted intothe web means that is sunk-in in the band body, wherein the slide meanscan be attached in an adjustable manner to the corresponding guidingmechanism by means of a locking mechanism that is also not shown indetail.

FIG. 7 shows a headband variant comprising a cushion body M which ismade of a foamed material and in which a tensile proof or stiff layer Eis embedded. The tensile proof layer E comprises a locking means 16which forms a guiding web having locking teeth 20. A slide element 21 isarranged on this guiding web. The slide element 21 can be moved in thedirections shown by the arrow P by applying a pushbutton 22 which causesunlocking of the locking mechanism that is not shown in detail. Theslide element 21 has a bracket or strap portion 18 through which a bandportion 11, 12 of the headband means can be passed. The band portion 11,12 is provided with a hook and loop fastener 24 for roughly andpreliminarily adjusting the effective lengths of the correspondingheadband portions 3, 4.

Alternatively to the shown attachment of the headband portion 11, 12 tothe bracket portion 18, it is also possible to couple the slide element21, as schematically shown in FIG. 18, with a breathing mask 2, namelyin that the bracket portion 18 is embedded in a firmly sewn band bracket25 and the attachment to the breathing mask 2 is realized by a bandbracket 27 passed through a mounting bracket 26 of the breathing mask 2,wherein the band bracket 27 is realized by a hook and loop fastener 28in a detachable manner. The slide element 21 can be moved along thelocking means 16. The locking means 16 can also be realized by a webmeans that is sunk-in in the band body (FIG. 6 a).

FIG. 9 shows a breathing mask user to which a further breathing maskarrangement 101 is fixed by means of an application device 102 which, inthe present embodiment, is realized as a headband arrangement. Thebreathing mask arrangement 101 comprises a mask base body 103 whichrests on the nose area of the user and is sealed by a sealing lip 105.The mask base body 103 is fixed to the user by means of a framestructure and a forehead supporting means 106 coupled thereto. Therespiratory gas can be supplied to the interior of the mask, which isdefined by the mask base body 103, via the connection means 107 that isonly shown schematically.

The application device 102 comprises an upper headband portion 108 whichextends from the area of the back of the head H in the area of theforehead supporting means 106. Furthermore, the application device alsocomprises a lower headband portion 109 which extends from the neck areaof the user across his/her cheekbones in the area of the mask base body103. In this embodiment, the corresponding headband portion 108, 109 iscoupled with the breathing mask arrangement 101 by means of hook andloop fastener structures which will be described in the following inconnection with FIG. 11. The application device is provided with asupporting structure S which, in the present embodiment, is formed by adimensionally stable plate material. The dimensionally stable platematerial is made of a material which is plastically deformable underspecific conditions and can thus be adapted to the individual shape ofthe back of the user's head. In this embodiment, the adaptability isachieved in that the material intended for forming the supportingstructure is a thermo-deformable plastic material. The materialproperties of this plastic material are adjusted such that this materialis plastically deformable at temperatures in the range starting fromabout 50° C. By using the supporting structure that is adapted to theindividual shape of the back of the head in accordance with the presentinvention, it becomes possible to apply the holding forces required forapplying the breathing mask arrangement 101 in a manner which isadvantageous in view of physiology. By adapting the supporting structureS to the individual shape of the user's head, it is in particularpossible to determine the course of the lower headband arrangement 109advantageously and, furthermore, achieve a high resistance againstslipping and twisting.

FIG. 10 is a rear view of the application device described above. It isevident from this view that the upper headband portion 8 is passedacross the area of the back of the user's head. The portion 8 a of theupper headband portion which bridges the area of the back of the head iscoupled with the lower band arrangement of the application device 102,which extends in the area of the back of the user's head, by means of avertical web 9 as well as by means of diagonal webs 110, 111. Theheadband means comprises said supporting structure S in the area of theback of the patient's head. This supporting structure S is adapted tothe individual shape of the back of the user's head. The supportingstructure S has openings for achieving an increased permeability tovapor.

It is evident from FIG. 11 that the supporting structure S comprises alower edge portion UR having leg portions S1, S2 which are arranged soas to guide the correspondingly assigned band portion 109 in such amanner that this band portion extends in an advantageous manner acrossthe cheek area of the mask user. In this embodiment, the supportingstructure comprises two further leg portions S3, S4 for guiding theupper band portions 108 of the headband means.

The headband portions 108, 109 are provided with hook and loop fasteners112, 113 for detachably coupling the headband portions 8, 9 withcorresponding bracket or strap portions of the breathing maskarrangement 101.

FIG. 12 is a simplified cross-sectional sketch showing a preferredembodiment of the application device in the area of the supportingstructure S. The supporting structure S is provided with a cushion bodyPK. In this embodiment, the cushion body PK is formed of a foamedmaterial which is embedded in a textile layer TL. The textile layer TLcan be configured so as to provide a coupling surface 114 which makes itpossible to couple the thus configured, cushioned supporting structuremeans detachably to the headband means 108, 109 by means of a hook andloop fastener. The supporting structure S has openings D for increasingits permeability to vapor.

The invention is not restricted to the embodiments described above.Alternatively to realizing the supporting structure S by athermo-deformable material, it is also possible to make the supportingstructure of a material which can be adapted to the shape of the back ofthe user's head in a different manner and which maintains thisindividual shape in a sufficiently dimensionally stable manner. Inparticular, this can be achieved by using curing materials, e.g. resins.The supporting structure S can be pre-shaped in such a manner that ithas a curvature which takes into account the most probable shape of theback of the head, so that a further adaptation is possibly not required.

The concept of using a temporarily plastifiable dimensionally stablestructure can be used advantageously in combination with the concept offorming the band body by foam injection molding, wherein the latterconcept is also in accordance with the present invention. In particular,it is possible to make the tensile proof structures, which are mentionedin view of the foam injection molding concept, at least in the area ofthe back of the head of a material which is temporarily plastifiable,e.g. under the influence of heat, or which is at least sufficientlymoldable.

1-20. (canceled)
 21. A supporting structure for a headband to support abreathing mask to a user, comprising: a stiffening layer; a cushionlocated on an inner side of the supporting structure adapted to face theuser in an application position; and a coupling surface adapted toreleasably couple the supporting structure with the headband.
 22. Thesupporting structure according to claim 21, wherein the supportingstructure is adapted to be located at the area of the back of the user'shead.
 23. The supporting structure according to claim 21, wherein thesupporting structure is adapted to be located at a height of the user'sear or in an area of the end of the user's cervical vertebra.
 24. Thesupporting structure according to claim 21, wherein the supportingstructure is constructed of a material which is adaptable to theindividual shape of the back of the user's head and which maintains theindividual shape in a sufficiently dimensionally stable manner.
 25. Thesupporting structure according to claim 21, wherein the supportingstructure is at least partially plastically deformable under specificconditions.
 26. The supporting structure according to claim 25, whereinthe supporting structure comprises a thermo-deformable material.
 27. Thesupporting structure according to claim 21, wherein the supportingstructure comprises a plastic material, a thermoplastic material or acured resin material.
 28. The supporting structure according to claim27, wherein the supporting structure is at least partially adaptable tothe back of the user's head while the material is not yet completelycured.
 29. The supporting structure according to claim 21, wherein thesupporting structure comprises a material which is at least partiallyplastically deformable at temperatures of at least 30° C.
 30. Thesupporting structure according to claim 21, wherein the supportingstructure is at least partially pre-shaped taking into account the mostprobable shape of the back of the user's head.
 31. The supportingstructure according to claim 21, wherein the cushion at least partiallycomprises a foamed and/or nonwoven material.
 32. The supportingstructure according to claim 21, wherein the cushion is at leastpartially embedded in a textile layer.
 33. The supporting structureaccording to claim 32, wherein the textile layer is at least partiallyconfigured so as to provide the coupling surface.
 34. The supportingstructure according to claim 21, wherein the coupling of the supportingstructure to the headband comprises a hook and loop fastener.
 35. Thesupporting structure according to claim 21, wherein the stiffening layercomprises at least one opening.
 36. The supporting structure accordingto claim 21, wherein the supporting structure is configured as a curvedplate element.
 37. The supporting structure according to claim 21,wherein the supporting structure comprises lower leg portions to guiderespective lower band portions of the headband.
 38. The supportingstructure according to claim 21, wherein the supporting structurecomprises upper leg portions to guide respective upper band portions ofthe headband.
 39. The supporting structure according to claim 37,wherein the lower band portions are adapted to extend in the applicationposition across the user's cheekbones.
 40. The supporting structureaccording to claim 38, wherein the upper band portions are adapted toextend in the area of the user's forehead.
 41. The supporting structureaccording to claim 21, wherein the supporting structure is adapted to atleast partially determine the course of the headband so as to increaseat the resistance against slipping and/or twisting.
 42. A process forproducing a supporting structure according to claim 21, comprisingforming the stiffening layer by injecting a plastic material in amolding tool space in a first plastic injection step, and, in asubsequent plastic injection step, injecting a pore-forming plasticmaterial in a molding tool in such a manner that it at least partiallycovers the stiffening layer to form the cushion.
 43. An applicationdevice for a breathing mask comprising a headband and a supportingstructure according to claim 21.